WO2020012417A1

WO2020012417A1 - Visual detection for iv pump tube calibration

Info

Publication number: WO2020012417A1
Application number: PCT/IB2019/055938
Authority: WO
Inventors: Eyal BARMAIMON; Lior Shtram; Shai Finkman; Elie YAACOBI; Ronny BELLAN; Nadav Cohen; Amit SCHNELL
Original assignee: Barmaimon Eyal; Lior Shtram; Shai Finkman; Yaacobi Elie; Bellan Ronny; Nadav Cohen; Schnell Amit
Priority date: 2018-07-11
Filing date: 2019-07-11
Publication date: 2020-01-16
Also published as: US10898640B2; US20210146034A1; US20200016327A1

Abstract

A system and method for calibrating an IV pump infusion system tube comprises a fluid source, an infusion system comprising, an IV pump, a drive unit, a chamber with known constant volume, a control unit, and IV tubing with a known inner diameter tolerance, and a sensor and floating detection object. The system administers medicinal fluid, calculates the flow rate of the medicinal fluid in the chamber by measuring the time the floating detection object and medicinal fluid rises in the chamber, compares the calculated flow rate with a set flow rate of the IV pump input in the control unit prior to infusion, and adjusts the IV pump and flow rate based on the compared deviations for more accurate delivery to a patient. This configuration may provide a more precise delivery rate of medicinal fluid, preventing harm to the patient and waste of medicine.

Description

VISUAL DETECTION FOR IV PUMP TUBE CALIBRATION

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Application No. 16/032,565, filed on July

1 1 , 2018, which is incorporated by reference as if fully set forth. This application is related to commonly owned and co-pending U.S. Application No. 16/032,555, filed on July 1 1 , 2018, and commonly owned and co-pending U.S. Application No. 16/032,527, filed on July 1 1 , 2018, which are incorporated by reference as if fully set forth.

SUMMARY

[0002] A system and method for calibrating flow rate of an IV pump infusion system comprising a fluid source, an infusion system comprising a control unit, an IV pump, a drive unit, and a chamber with known constant volume comprising an inlet on one side and a lower outlet on the opposite side, and IV tubing with a known inner diameter tolerance configured to operatively couple the fluid source to the inlet of the chamber, and the outlet of the chamber to a patient. The control unit is configured to operate the drive unit, and further configured to measure the amount of time the medicinal fluid takes to rise from a first (initial) position to a second (filled) position of the chamber, calculate the flow rate of the medicinal fluid in the chamber, compare the calculated flow rate with a pre-set flow rate of the IV pump input into the control unit prior to infusion, and adjust the IV pump and flow rate based on the compared deviation.

BRIEF DESCRIPTION OF THE DRAWINGS

[0003] The present invention is illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings in which:

[0004] FIG. 1 is a schematic block diagram of an IV infusion flow rate calibration system.

[0005] FIG. 2 is a diagram of an IV infusion flow rate calibration system chamber with a detection mechanism in two filling phases.

[0006] FIG. 3 is a simple flow diagram of a method of calibration for an IV pump infusion system.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0007] Intravenous (“IV”) infusion is a popular type of therapy that efficiently delivers liquid substances to a patient directly through a vein. IV infusion is necessary for the treatment of a variety of broad ranging diseases, conditions, and symptoms. The infusion system, delivery method, and flow and dosage details are therefore imperative in determining effective drug administration and therapy. [0008] IV pumps play a crucial role in delivering fluids and complex doses of medications to patients in a wide range of care settings. Currently, medications and pharmaceutical drugs administered through the IV pump attempt to infuse at a smooth and continuous flow rate that is input into the infusion system prior to infusion. Delivery accuracies, however, greatly vary. IV pump inaccuracies typically result from the disposable infusion systems used.

[0009] One reason for inaccuracies in infusion systems is because the systems have a common tube inner diameter tolerance of ±0.05 mm. This variance of inner diameter tolerance causes the volume of substance being delivered through the IV infusion system to be determined by the actual inner diameter. As a result, drug delivery to a patient may not be precise and could result in harm to the patient or wasting of the medication or substance to be administered.

[0010] It would therefore be beneficial to offer an IV infusion system with flow or volume measurement calibration that calculates the flow rate of a medicinal substance and adjusts the infusion system according to any deviations found, to help improve substance-delivery accuracy.

[001 1] FIG. 1 is a schematic block diagram of an IV infusion and calibration system 100 in accordance with the teachings herein. The infusion and calibration system 100 comprises a fluid source 102, IV tubing 104, and an infusion system 106. The infusion system 106 may include a control unit 108, an IV pump 1 12, a drive unit 1 14, and a calibration chamber 1 16.

[0012] In the present embodiment as described hereinafter, the calibration chamber 1 16 may be used in IV infusion therapies, and for purposes of explanation, the IV infusion and calibration system 100 will be described with reference to IV infusion. However, those of skill in the art would realize that in other embodiments, the calibration chamber 1 16 may be used to perform other therapeutic or diagnostic procedures. During IV infusion, a practitioner may use an IV pump to deliver a precise amount of medicinal fluid into a patient’s vein over a controlled period of time. Linear peristaltic pumps are typically used in order to maintain sterilization of the IV infusion system. These pumps require a peristaltic apparatus that occludes a resilient IV tube through which the IV fluid is pumped. The tubing is compressed against a stationary plate and the compression and decompression regulate the desired flow. When the tubing occludes, the tubing forces the fluid to go through the patient’s vessel at a pre-selected rate.

[0013] Current manufactured tubing for linear peristaltic IV pumps, however, vary slightly in inner diameter and outer diameter size. Consequently, these tubes have an inner diameter (“ID”) tolerance of ±0.05 mm or more. This tolerance effect ultimately impacts the volume inside the tube. For example, the nominal volume of an IV tube is currently calculated using the following equation:

Equation (1 )

In contrast, the maximum volume of the IV tube, taking into consideration the -+O.05 mm tolerance, is calculated as follows:

Equation (2)

And the minimum volume of the IV tube, taking into consideration the -0.05 mm tolerance, is calculated as follows: Equation (3)

As a result, the current tolerance effect of IV tubing inner diameters provides approximately a ±3.5% change in volume inside the tube when using a tube with 3 mm ID, which is common in IV settings. Having a tube volume deviation of ±3.5% makes it difficult to effectively administer the precise amount of medicinal fluid over a specific time to a patient, since the volume inside the tubing varies. The inability to measure the exact flow rate of fluid inside the tubing without expensive in-line products also makes it difficult to combat the variance in administration due to tube volume deviation. As a result, the patient may be administered more or less medicine than the required dosage, which could ultimately harm the patient. Administering an excess dosage of medicinal fluid also unnecessarily wastes expensive medicine.

[0014] Returning to FIG. 1 , in the present embodiment, the IV infusion and calibration system 100 calculates the flow rate of medicinal fluid using the chamber 1 16, during priming, and then compares the calculated flow rate with the input flow rate in the IV pump 1 12 in order to calibrate and adjust infusion for more accurate medicine delivery. The flow rate is calculated by measuring the amount of time the medicinal fluid rises inside the chamber 1 16 of the infusion system 106 from a first designated level to a second designated level.

[0015] Prior to infusion, a set rotational speed and equivalent flow rate for the IV pump 1 12 is input into the control unit 108. When infusion begins, the medicinal fluid stored in the fluid source 102 flows through the IV tubing 104 and to a patient 1 18. The control unit 108 may begin infusion by communicating with the drive unit 114 to operate the IV pump 1 12. The control unit 108 may comprise a microprocessor 108A and a memory 108B. In other embodiments, the control unit 108 may use other types of logic devices for driving the drive unit 1 14, such as a hardwired logic control, an application specific integrated circuit, etc. In one embodiment, the drive unit 1 14 may comprise an electrical motor to drive the IV pump 112. In the present embodiment, the IV pump 1 12 is a standard peristaltic pump. Accordingly, the IV tubing 104 is a standard manufactured tubing commonly used with peristaltic IV pumps, and thus has an ID tolerance of approximately ±.05 mm. [0016] As infusion continues, medicinal fluid stored in the fluid source 102 flows through the IV tubing 104 into the infusion system 106. In the embodiment set forth in the drawings and as described hereinafter, the fluid source 102 is an IV bag, however that is just by way of example. In other embodiments, the fluid source 102 may be any sterilized container able to store the medicinal fluid. The medicinal fluid flows through the IV tubing 104 in the infusion system 106 and flows into the chamber 1 16. In the present embodiment, the chamber 1 16 is a cylindrical hollow thermoplastic chamber with an inlet 1 16A and an outlet 116B for the medicinal fluid to flow through. The chamber 1 16 has a constant pre-measured volume that is inputted into the control unit 108. As medicinal fluid flows into the chamber 1 16 via the inlet 1 16A, the control unit 108 determines the time it takes for the medicinal fluid to fill the chamber 1 16 by measuring the duration of the rising fluid from a specified first (initial) position in the chamber 1 16 to a specified second (filled) position in the chamber 1 16.

[0017] Several different mechanisms may be used to determine the fluid level and filling duration in the chamber 1 16. In one embodiment, the chamber 1 16 may comprise a detection mechanism. The detection mechanism may include a sterilized floating object in the chamber 116 and one or more imaging sensors that detects the rise of the medicinal fluid as the sterilized object floats and rises. In another embodiment, the chamber 1 16 may comprise a reed switch mechanism. The reed switch mechanism may comprise a floating magnetic object in the chamber 1 16 and an open reed switch along the outside of the chamber 116 that detects the rise of the fluid when the magnetic ball approaches and closes the switch. In yet another embodiment, the chamber 1 16 may comprise a capacitor mechanism. The capacitor mechanism may include conductive plates on the outside of the chamber 1 16 that determine the fluid level based on the changing capacitance of the fluid as it fills the chamber. In other embodiments, the fluid level and filling durations may be detected by a Hall Effect sensor in the chamber or various imaging sensor mechanisms.

[0018] The duration information for the rising medicinal fluid in the chamber 116 and the fluid levels in the chamber 1 16 are communicated to, and stored in, the control unit 108. In one embodiment, the chamber 1 16 may be communicatively connected to the control unit 108 through electrical wiring. In another embodiment, the chamber 116 may be communicatively connected to the control unit 108 wirelessly. The microprocessor 108A may comprise a general-purpose computer, with suitable front end and interface circuits for receiving signals from the chamber 1 16 and controlling the other components of the infusion system 106. The microprocessor 108A may be programmed in software to carry out the functions described herein. The software may be downloaded in electronic form, over a wired or wireless network, for example, or it may be provided on tangible media, such as optical, magnetic or electronic memory media. In other embodiments, some or all of the functions of the microprocessor 108A may be carried out by dedicated or programmable digital hardware components. The control unit 108 then calculates the flow rate of the medicinal fluid in the chamber 116 using the equation:

Flow rate = ^{VO lUme}chamber Equation (4)

Where volume_Cham_ber\s the input volume of the chamber 116, and At is the time taken for the fluid to rise from the specified first (initial) position in the chamber 1 16 to the specified second (filled) position.

[0019] The control unit 108 may calculate the volume and flow rate of the medicinal fluid as it rises in the chamber 1 16. The control unit 108 may store the calculated flow rate values in the memory 108B. The control unit 108 may compare the calculated volume and flow rate of the medicinal fluid with the input rotational speed and equivalent flow rate of the IV pump 1 12 prior to infusion. If the calculated flow rate of the medicinal fluid deviates from the pre-set flow rate from the IV pump 112, the control unit 108 may communicate with the drive unit 1 14 and the IV pump 1 12 to calibrate the IV pump 1 12 to a rotational speed to achieve an accurate flow rate delivery. In one embodiment, the IV pump 1 12 may be communicatively connected to the control unit 108 through electrical wiring. In another embodiment, the IV pump 1 12 may be communicatively connected to the control unit 108 wirelessly. The control unit 108 and the drive unit 1 14 may adjust the IV pump 1 12 via the motor. The control unit 108 and drive unit 1 14 therefore adjusts the volume and flow rate based on the speed of the IV pump 1 12 to achieve the precise and required medicine delivery to the patient 1 18. The medicinal fluid leaves the chamber 1 16 via the outlet 116B and is then delivered into the patient 1 18 through additional IV tubing 104 with improved volume accuracy and flow rate.

[0020] FIG. 2 is a diagram of a calibration system chamber 200 with a detection mechanism 202 in two filling phases. The chamber 200 has a known, constant volume. In phase I, medicinal fluid 204 enters the chamber 200 via an inlet 200A. The detection mechanism comprises a detection object 202B and a sensor 202A. In the embodiment set forth in the drawings and as described hereinafter, the detection object 202B is a lightweight, floating ball, however that is just by way of example. In other embodiments, the detection object 202B may be any object that is lightweight enough such that the object floats as the medicinal fluid 204 fills the chamber 200.

[0021] As medicinal fluid 204 fills the chamber 200, the detection object 202B begins to rise. The sensor 202A detects the detection object 202B as the detection object 202B passes an initial filling position Po. The sensor 202A continues to detect the detection object 202B until the detection object 202B passes a subsequent filled position Pi (depicted in phase II). Upon initial detection of the detection object 202B, the sensor 202A communicates with a control until (not depicted) to measure the time taken for the medicinal fluid 204 to fill the chamber. This time is measured from when the sensor 202A initially detects the detection object 202B at the initial filling position Po until the sensor 202A can no longer detect the detection object 202B at the subsequent filled position Pi. Once the medicinal fluid 204 fills the chamber 200 past the subsequent filled position Pi, the medicinal fluid 204 begins to exit the chamber 200 via the outlet 200B.

[0022] In one embodiment, the sensor 202A may be a visual imaging sensor that detects the image, shape, or color of the detection object 202B as it passes the sensor 202A. In another embodiment, the sensor 202A may be a magnetic position sensor and the detection object 202B may include a magnet. The magnetic position sensor may generate signals that are used to determine position coordinates of the magnetic detection object as it passes the sensor.

[0023] FIG. 3 is a simple flow diagram of a method of flow rate measurement and calibration for an IV infusion system. A set rotational speed and equivalent flow rate of the IV pump is set and input into the infusion system. The medicinal fluid is released from a fluid source and enters the infusion system (S1 ). The IV infusion and calibration system measures the time it takes for the fluid to fill a chamber with a known, constant volume in the infusion system (S2). The system may measure this duration by determining the amount of time the fluid rises past two predetermined height positions using a visual detection sensor and a visual floating object that rises as the medicinal fluid rises and is detected by the visual detection sensor.

[0024] The IV infusion and calibration system calculates the flow rate of the medicinal fluid in the chamber (S3). Based on the calculated flow rate, the IV infusion and calibration system compares the calculated flow rate with the set flow rate of the IV pump (S4). As a result, the IV infusion and calibration system may calibrate and adjust the IV pump and flow rate based on the compared deviations in order to provide more accurate required dosage of medicine over a more precise duration (S5).

[0025] Having thus described the presently preferred embodiments in detail, it is to be appreciated and will be apparent to those skilled in the art that many physical changes, only a few of which are exemplified in the detailed description of the invention, could be made without altering the inventive concepts and principles embodied therein. It is also to be appreciated that numerous embodiments incorporating only part of the preferred embodiment are possible which do not alter, with respect to those parts, the inventive concepts and principles embodied therein. The present embodiments and optional configurations are therefore to be considered in all respects as exemplary and/or illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all alternate embodiments and changes to this embodiment which come within the meaning and range of equivalency of said claims are therefore to be embraced therein.

Claims

CLAIMS What is claimed is:

1. A calibration system for IV pump infusion, comprising:

a chamber with constant volume comprising an inlet and an outlet, the chamber configured to allow medicinal fluid to enter via the inlet and exit via the outlet;

a floating detection object configured to float in the medicinal fluid; and

a sensor coupled to the chamber and configured to measure the amount of time the medicinal fluid rises from a first position in the chamber up to a second position based on the amount of time the floating detection object in the medicinal fluid rises, and transmit this measurement to an IV pump control unit.

2. The calibration system according to claim 1 , wherein the sensor is coupled between the first position and the second position, and further configured to continuously detect the floating detection object as it passes the first position and completely passes the second position when the medicinal fluid rises.

3. The calibration system according to claim 1 , wherein the sensor is a visual image sensor and is further configured to detect a specific color or shape and the floating detection object is an object having the specified color or shape.

4. The calibration system according to claim 1 , wherein the floating detection object is a floating ball.

5. The calibration system according to claim 1 , wherein the IV pump control unit comprises:

a microprocessor configured to:

receive an input flow rate,

calculate flow rate data of the medicinal fluid in the chamber based on the measured amount of time the medicinal fluid rises, and

compare the calculated data with an input flow rate; and

a memory configured to store the calculated and compared data and the measured amount of time the medicinal fluid rises.

6. The calibration system according to claim 1 , wherein the medicinal fluid exits the chamber via the outlet when the medicinal fluid fills the chamber past the second position.

7. A method of calibrating a flow rate of an IV pump infusion system, comprising the steps of:

setting a flow rate for an IV pump of the infusion system;

administering medicinal fluid to the infusion system; measuring the amount of time taken for the medicinal fluid to rise from an initial filling position to a second position in a chamber of the infusion system via a sensor and a floating detection object;

calculating a flow rate of the medicinal fluid inside the chamber based on the volume of the chamber and the measured amount of time taken for the medicinal fluid to rise from the initial filling position to the second position;

comparing the calculated flow rate of the medicinal fluid inside the chamber with the set flow rate of the IV pump; and

adjusting the IV infusion system flow rate and volume of medicinal fluid administered based on the compared flow rate deviation.

8. The method according to claim 7, wherein the chamber has a constant volume.

9. The method according to claim 8, wherein said measuring the amount of time taken for the medicinal fluid to rise from an initial filling position to a second position in a chamber further comprises:

sensing the floating detection object in the chamber as the object passes the initial filling position and completely passes the second position when the medicinal fluid rises.

10. The method according to claim 8, wherein the sensor is a visual image sensor and is coupled between the first position and the second position, and further configured to continuously detect the floating detection object as it passes the first position and completely passes the second position when the medicinal fluid rises.

1 1. The method according to claim 8, wherein the sensor is further configured to detect specific color or shape and the floating detection object is an object having the specified color or shape.

12. The method according to claim 8, wherein the floating detection object is a floating ball.